November 20, 2019

New Rule From FDA Allows Access to Food Records

The Food and Drug Administration has issued an interim final rule allowing the agency expanded access to food company records. Under this rule, the FDA can request records beyond those associated with a particular suspect food if it believes that other products may be affected and are a threat to humans or animals.

This amendment will take effect March 1, 2012 as part of the Food Safety Modernization Act. The record keeping is mandatory for all handlers, producers, and growers of food, feed, ingredients, and beverages.

“The FDA can now access records if [it] believes that there is a reasonable probability that the use of or exposure to an article of food, and any other article of food that FDA reasonable believes is likely to be affected in a similar manner, will cause serious adverse health consequences or death to humans or animals. Decisions regarding whether FDA ‘reasonably believes’ a food is affected … would be made on a case-by-case basis because such decisions are fact-specific.

Such records and other information must be made available as soon as possible, not to exceed 24 hour from the time of receipt of the official request.”

The government believes this rule will help them stop harmful food from reaching the market, improving the safety of our food supply. If you’d like to comment on this rule, visit Regulations.gov by May 23, 2012.

To help industry comply with this new rule, the government has published a guidance document on questions and answers regarding establishment and maintenance of records.

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